[Translation] A double-blind, randomized, placebo-controlled trial evaluating the efficacy, pharmacokinetics, and safety of remibrutinib (LOU064) in adolescent patients aged 12 to < 18 years for the treatment of chronic spontaneous urticaria inadequately controlled with H1 antihistamines for 24 weeks, followed by an optional open-label extension period of up to 3 years and an optional additional long-term safety follow-up period without treatment of up to 3 years

本研究（即核心期）的目的是在H1抗组胺药（H1-AH）控制不佳的12至 < 18岁慢性自发性荨麻疹青少年患者中评估remibrutinib（LOU064）vs. 安慰剂的疗效、药代动力学和安全性。开放性扩展（OLE）期的目的是收集完成核心期（即24周治疗）后的青少年接受remibrutinib治疗的长期疗效、安全性和耐受性数据。诺华还将通过该扩展期履行承诺，即为参加前一个核心期的受试者提供试验后供药。长期无治疗随访（LTTFFU）期的目的是收集该人群在OLE 期接受末次治疗后最长3年的安全性数据。

[Translation]

The purpose of this study (i.e., core phase) is to evaluate the efficacy, pharmacokinetics, and safety of remibrutinib (LOU064) vs. placebo in adolescents aged 12 to < 18 years with chronic spontaneous urticaria that is inadequately controlled with H1 antihistamines (H1-AH). The purpose of the open-label extension (OLE) phase is to collect long-term efficacy, safety, and tolerability data for adolescents receiving remibrutinib after completing the core phase (i.e., 24 weeks of treatment). This extension phase will also fulfill Novartis' commitment to provide post-trial drug supply to subjects who participated in the previous core phase. The purpose of the long-term treatment-free follow-up (LTTFFU) phase is to collect safety data for this population up to 3 years after the last treatment in the OLE phase.

Start Date07 May 2024

Sponsor / Collaborator

China Novartis Institutes for BioMedical Research Co., Ltd.

CTR20240112 / RecruitingPhase 3

一项评价remibrutinib（LOU064）在H1抗组胺药控制不佳的慢性诱导性荨麻疹（CINDU）成人患者中治疗52周的疗效、安全性和耐受性的多中心、随机、双盲、安慰剂对照、篮式研究（含开放性扩展期）

[Translation] A multicenter, randomized, double-blind, placebo-controlled, basket study (with an open-label extension phase) to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) for 52 weeks in adult patients with chronic induced urticaria (CINDU) inadequately controlled with H1 antihistamines

本研究的目的是评价remibrutinib相比安慰剂治疗H1抗组胺药控制不佳的CINDU成人患者的疗效、安全性和耐受性。

[Translation]

The purpose of this study was to evaluate the efficacy, safety, and tolerability of remibrutinib compared with placebo in adult patients with CINDU who were inadequately controlled with H1 antihistamines.

Start Date26 Mar 2024

Sponsor / Collaborator

China Novartis Institutes for BioMedical Research Co., Ltd.

CTRI/2024/01/061150 / RecruitingPhase 3

A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies. - LOU064 Roll over

Start Date05 Feb 2024

Sponsor / Collaborator

Novartis Healthcare Pvt Ltd.

100 Clinical Results associated with Remibrutinib

100 Translational Medicine associated with Remibrutinib

100 Patents (Medical) associated with Remibrutinib

Literatures (Medical) associated with Remibrutinib

01 Dec 2023·Biomedical chromatography : BMC

Metabolite profiling of remibrutinib in rat and human liver microsomes using liquid chromatography combined with benchtop orbitrap high‐resolution mass spectrometry

Article

Author: Lu, Lingpan ; Li, Wenyuan ; Liu, Jinhai ; Qiu, Mingheng ; Qiao, Min ; Lai, Xinxin

Abstract:

Remibrutinib is a potent and highly selective covalent Bruton's tyrosine kinase inhibitor that is undergoing clinical development for the treatment of autoimmune diseases. The present study was undertaken to investigate the in vitro metabolism of remibrutinib and to propose its biotransformation pathways. The metabolites were generated by incubating remibrutinib (2 μm) with human and rat liver microsomes at 37°C for 30 min. Ultra‐high‐performance liquid chromatography combined with benchtop orbitrap high‐resolution mass spectrometry was used to identify and characterize the metabolites of remibrutinib. Compound Discoverer software was employed to process the acquired data. In rat liver microsomes, a total of 18 metabolites have been identified and characterized among which three (M8, M12 and M13) were identified as the most abundant metabolites. In human liver microsomes, a total of 16 metabolites have been identified, and M8 and M12 were identified as the predominant metabolites. All the metabolites were nicotinamide adenine dinucleotide phosphate dependent. The major metabolic changes were found to be oxygenation, dealkylation, demethylation, epoxidation and hydrolysis. The present study comprehensively reports the in vitro metabolism of remibrutinib mentioning 20 metabolites. These findings will help investigation of remibrutinib disposition and safety evaluation.

01 Dec 2023·The Journal of allergy and clinical immunology

BTK signaling—a crucial link in the pathophysiology of chronic spontaneous urticaria

Review

Author: Maurer, Marcus ; Saini, Sarbjit S ; Bernstein, Jonathan A

Chronic spontaneous urticaria (CSU) is an inflammatory skin disorder that manifests with itchy wheals, angioedema, or both for more than 6 weeks. Mast cells and basophils are the key pathogenic drivers of CSU; their activation results in histamine and cytokine release with subsequent dermal inflammation. Two overlapping mechanisms of mast cell and basophil activation have been proposed in CSU: type I autoimmunity, also called autoallergy, which is mediated via IgE against various autoallergens, and type IIb autoimmunity, which is mediated predominantly via IgG directed against the IgE receptor FcεRI or FcεRI-bound IgE. Both mechanisms involve cross-linking of FcεRI and activation of downstream signaling pathways, and they may co-occur in the same patient. In addition, B-cell receptor signaling has been postulated to play a key role in CSU by generating autoreactive B cells and autoantibody production. A cornerstone of FcεRI and B-cell receptor signaling is Bruton tyrosine kinase (BTK), making BTK inhibition a clear therapeutic target in CSU. The potential application of early-generation BTK inhibitors, including ibrutinib, in allergic and autoimmune diseases is limited owing to their unfavorable benefit-risk profile. However, novel BTK inhibitors with improved selectivity and safety profiles have been developed and are under clinical investigation in autoimmune diseases, including CSU. In phase 2 trials, the BTK inhibitors remibrutinib and fenebrutinib have demonstrated rapid and sustained improvements in CSU disease activity. With phase 3 studies of remibrutinib ongoing, it is hoped that BTK inhibitors will present an effective, well-tolerated option for patients with antihistamine-refractory CSU, a phenotype that presents a considerable clinical challenge.

01 Feb 2024·The Journal of allergy and clinical immunology

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks

Article

Author: Lheritier, Karine ; Tillinghast, Jeffrey ; Reich, Adam ; Walsh, Pauline ; Dahale, Swapnil ; Zharkov, Artem ; Giménez-Arnau, Ana ; Hayama, Koremasa ; Carr, Warner ; Hugot, Sophie ; Jain, Vipul ; Haemmerle, Sibylle

BACKGROUND:

Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with second-generation H1 antihistamines. It is currently in phase 3 development for CSU.

OBJECTIVE:

We sought to evaluate long-term safety and efficacy of remibrutinib in patients with CSU inadequately controlled with H₁ antihistamines.

METHODS:

In this phase 2b extension study, patients who completed the core study and had a weekly Urticaria Activity Score (UAS7) ≥16 at the beginning of the extension study received remibrutinib 100 mg twice daily for 52 weeks. The primary objective was to assess long-term safety and tolerability. Key efficacy end points included change from baseline in UAS7 and proportion of patients with complete response to treatment (UAS7 = 0) and well-controlled disease (UAS7 ≤6) at week 4 and over 52 weeks.

RESULTS:

Overall, 84.3% (194/230) of patients entered the treatment period and received ≥1 doses of remibrutinib. The overall safety profile of remibrutinib was comparable between the extension and core studies. Most treatment-emergent adverse events were mild to moderate and considered unrelated to remibrutinib by investigators. The 3 most common treatment-emergent adverse events by system organ class were infections (30.9%), skin and subcutaneous tissue (26.8%), and gastrointestinal disorders (16.5%). At week 4 and 52, mean ± SD change from baseline in UAS7 was -17.6 ± 13.40 and -21.8 ± 10.70; UAS7 = 0 (as observed) was achieved in 28.2% and 55.8% and UAS7 ≤6 (as observed) was achieved in 52.7% and 68.0% of patients, respectively.

CONCLUSIONS:

Remibrutinib demonstrated a consistent favorable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU.

News (Medical) associated with Remibrutinib

31 May 2024

·www.globenewswire.com

Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria

Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and sustained to 1 year (Week 52)1 Remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, demonstrated a favorable and consistent safety profile up to 1 year, including balanced liver function tests versus placebo1 Novartis intends to submit remibrutinib for approval in chronic spontaneous urticaria (CSU) to global health authorities starting in H2 2024, and continues to investigate remibrutinib in multiple immune-mediated conditions Data reaffirm the first-in-class potential of remibrutinib for the more than 50% of patients with CSU uncontrolled by H1-antihistamines who continue to live with painful and debilitating symptoms1,2 May 31, 2024 – Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU)1. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early, which was sustained up to Week 52, in patients with CSU who remained symptomatic despite second-generation H1-antihistamine use1. These data are being presented at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain, May 31–June 3. “A large majority of people with CSU are living with uncontrolled and debilitating symptoms, often trying to manage the condition by cycling through antihistamines at higher doses with no lasting respite, impacting heavily on their day-to-day lives,” said Martin Metz, Professor of Dermatology, Charité – Universitätsmedizin Berlin, Germany. “Remibrutinib has become an important investigational treatment for CSU as it blocks the BTK cascade and inhibits the release of histamine. These data show that remibrutinib has the potential to offer patients and physicians a well-tolerated oral treatment that provides early and lasting efficacy.” New long-term Phase III REMIX-1 and REMIX-2 data assessed at Week 52 show that1: Significant improvements with remibrutinib versus placebo, as previously shown at Week 12, were confirmed at Week 24, including in weekly urticaria activity score (UAS7), weekly itch severity score (ISS7), and weekly hive severity score (HSS7) At Week 24, patients receiving placebo were transitioned to remibrutinib; responses with remibrutinib were observed as early as the first week after switching and were sustained until the end of the study (28 weeks of treatment) Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 “Living with CSU can be very distressing due to its unpredictable nature and never knowing when a flare-up may happen. Symptoms can occur on the face, throat, hands, and feet, and people may experience burning and pain on their skin,” said Tonya Winders, President and CEO, Global Allergy and Airways Patient Platform. “Unfortunately, many people continue to cope with uncontrolled symptoms. We welcome further research advancing our knowledge about chronic spontaneous urticaria.” Remibrutinib was well-tolerated and demonstrated a favorable and consistent safety profile up to 52 weeks, including balanced liver function tests versus placebo1. Adverse events (AEs), including serious AEs and treatment discontinuations due to AEs, were comparable between remibrutinib and placebo during the 24-week placebo-controlled period1. In addition, exposure-adjusted rates did not increase with long-term treatment1. Liver transaminase elevations were balanced across the remibrutinib and placebo treatment groups; all were asymptomatic, transient, and reversible1. None of the serious AEs were considered related to study medication by investigators. “Urticaria is a disease that significantly impacts patients' quality of life and there is an urgent need for new treatment options,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis. “The 52-week REMIX-1 and REMIX-2 Phase III data are significant as many patients who had moderate to severe urticaria at study start were completely free of itch and hives after 52 weeks of treatment and remibrutinib, a highly selective oral BTK inhibitor, continued to be well tolerated. These exciting long-term data will be submitted to global health authorities later this year.” In addition to CSU, remibrutinib is being investigated in several other immune-mediated conditions, such as hidradenitis suppurativa, where it met its primary endpoint in a Phase II study3. It is also being investigated in food allergy, chronic inducible urticaria, and multiple sclerosis4-8. Novartis will submit remibrutinib for approval in CSU to global health authorities starting in H2 2024. Remibrutinib is an investigational, highly selective, covalent, oral BTK inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itchy hives (wheals) and swelling9-11. When remibrutinib is used alongside standard-dose antihistamines, it results in a “two-pronged approach” where two parts of the inflammatory pathway are targeted, with remibrutinib inhibiting histamine release and antihistamines inhibiting histamine receptors, reducing CSU symptoms12,13. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib met all primary endpoints in patients with CSU who remained symptomatic despite second-generation H1-antihistamine use1. Treatment with remibrutinib showed significant symptom improvement early, which was sustained up to Week 521. Remibrutinib has been shown to be well-tolerated, with a favorable safety profile up to 52 weeks, including balanced liver function tests versus placebo1. Most commonly (≥5%) observed AEs in the Phase III REMIX studies were respiratory tract infections (including COVID-19 and nasopharyngitis) and headache, all comparable with placebo1,14. If approved in CSU, remibrutinib would offer an effective oral option within the Novartis immunology portfolio, which currently includes Xolair® (omalizumab), the first and only injectable biologic indicated for CSU15. In the US, Novartis Pharmaceuticals Corporation and Genentech, a member of the Roche Group, work together to develop and co-promote Xolair. In addition to CSU, remibrutinib is being investigated in several other immune-mediated conditions and has the potential to be a pipeline in a product4-8. REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) are two identically designed, global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III studies, with REMIX-1 consisting of 470 participants and REMIX-2 consisting of 455 participants16,17. Both studies are designed to establish the efficacy, safety, and tolerability of twice-daily remibrutinib 25 mg treatment in adult participants with CSU that is inadequately controlled by second-generation H1-antihistamines compared with placebo1,16,17. The primary outcome measures were absolute change from baseline in weekly urticaria activity score (UAS7) as well as weekly itch severity score (ISS7) and weekly hive severity score (HSS7) at Week 1216,17. All participants were on a stable, local label-approved dose of a second-generation H1-antihistamine throughout the entire study16,17. CSU is the medical term for chronic hives that last for 6 weeks or longer, where the underlying cause is internal rather than exposure to any allergen or external trigger2,11,18. CSU affects approximately 40 million people worldwide2,19. It is characterized by the sudden appearance of itchy hives (wheals) and/or deep tissue swelling (angioedema, which can occur on the face, throat, hands, and feet)11,20. CSU affects all ages but occurs most frequently between the ages of 20–40 years, with women affected nearly twice as often as men2. CSU causes significant emotional distress, with the majority of patients suffering from sleep deprivation, and high rates of mental disorders, such as anxiety or depression, as well as impacting on their work productivity2. Antihistamines are often prescribed for CSU as they block histamine receptors and prevent the pro-inflammatory action of histamine, which causes itching and swelling13,18. However, more than 50% of people with CSU are uncontrolled by H1-antihistamines alone2. Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. References Metz M, Giménez-Arnau A, Hide M, et al. Long-term efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria in the Phase 3 REMIX-1 and REMIX-2 studies. Presented as a late oral abstract session on clinical trials at EAACI 2024; May 31-June 3, 2024; Valencia, Spain. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy 2011; 66: 317-330. Kimball A, Prens E, Bechara F, et al. Efficacy and safety of the oral Bruton’s tyrosine kinase inhibitor, remibrutinib, in patients with moderate to severe hidradenitis suppurativa in a randomized, phase 2, double-blind, placebo-controlled platform study. Presented as a late-breaking abstract at the American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, California. ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis. Available from: https://clinicaltrials.gov/study/NCT05147220 [Last accessed: May 2024]. ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from: https://clinicaltrials.gov/study/NCT05156281 [Last accessed: May 2024]. ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from: https://clinicaltrials.gov/ct2/show/NCT03827798. [Last accessed: May 2024]. ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from: https://clinicaltrials.gov/study/NCT05432388 [Last accessed: May 2024]. ClinicalTrials.gov. NCT05976243. Study to investigate efficacy, safety, and tolerability of remibrutinib compared with placebo in adults with CINDU inadequately controlled by H1-antihistamines. Available from: https://clinicaltrials.gov/study/NCT05976243. [Last accessed: May 2024]. Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (remibrutinib), a potent and highly selective covalent inhibitor of Bruton's Tyrosine Kinase. J Med Chem 2020; 63: 5102-5118. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565. Jain V, Giménez-Arnau A, Hayama K, et al. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol 2024; 153: 479-486. Patient. Antihistamines. Last updated 12 October 2022. Available from: https://patient.info/allergies-blood-immune/allergies/antihistamines [Last accessed: May 2024]. Novartis. Data on file. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. Xolair Omalizumab. Chronic Spontaneous Urticaria (CSU). Available from: https://www.xolair.com/chronic-spontaneous-urticaria.html [Last accessed: May 2024]. ClinicalTrials.gov. NCT05030311. A Phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1 antihistamines (REMIX-1). Available from: https://clinicaltrials.gov/study/NCT05030311 [Last accessed: May 2024]. ClinicalTrials.gov. NCT05032157. A Phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1- antihistamines (REMIX-2). Available from: https://clinicaltrials.gov/study/NCT05032157 [Last accessed: May 2024]. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy 2022; 77: 734-766. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultPhase 3

31 May 2024

·firstwordpharma.com

Novartis a step closer to filing remibrutinib in urticaria as long-term data emerge

Novartis is gearing up to file marketing applications in the second half of the year for its BTK inhibitor remibrutinib in chronic spontaneous urticaria (CSU) following the announcement on Friday of long-term findings from two Phase III studies. The results are scheduled to be presented at the European Academy of Allergy and Clinical Immunology (EAACI) congress.The identical REMIX-1 and REMIX-2 trials were designed to investigate twice-daily remibrutinib 25 mg compared with placebo in 470 and 455 adults, respectively, with CSU inadequately managed by second-generation H1-antihistamines. In top-line results released in August last year, the studies met their primary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity as early as week two. Efficacy sustainedThe new 52-week data further demonstrated significant improvements in weekly scores for urticaria activity (UAS7), itch severity (ISS7), and hive severity (HSS7) with remibrutinib versus placebo, consistent with the findings observed at week 12 and corroborated at week 24. Furthermore, more than half of the patients were completely free of itch and hives at week 52.The company also noted that placebo recipients who were switched to remibrutinib at week 24, showed responses as early as the first week after the transition, which persisted until the study's completion at 28 weeks.Angelika Jahreis, global head of development for immunology at Novartis, said “urticaria is a disease that significantly impacts patients' quality of life and there is an urgent need for new treatment options,” adding that many of the patients with moderate-to-severe disease at baseline could attain long-term relief from itch and hives with remibrutinib.Safety concerns addressedThe company added that remibrutinib showed favourable safety and tolerability for up to 52 weeks, with no serious adverse events deemed related to the drug. Increases in liver transaminases were balanced across the remibrutinib and placebo groups, with all occurrences being asymptomatic, temporary and reversible.In April last year, Novartis had clarified that there was no evidence of liver toxicity with remibrutinib, which had been a concern with other BTK inhibitors, including Merck KGaA’s evobrutinib, Sanofi’s tolebrutinib and Roche’s fenebrutinib. Apart from CSU, remibrutinib is being investigated for hidradenitis suppurativa, where it hit the main goal in a Phase II study, alongside food allergy, chronic inducible urticaria, and multiple sclerosis.

Clinical ResultPhase 2Phase 3

24 Apr 2024

·www.pharmaceutical-technology.com

Novartis reports 25% increase in net income in Q1 2024

As of 31 March 2024, Novartis’ net debt stood at $15.8bn. Credit: Michael Derrer Fuchs via Shutterstock. Novartis has reported net income from continuing operations of $2.68bn for the first quarter (Q1) of 2024, marking a 25% increase from $2.15bn in Q1 2023. This growth was primarily attributed to a surge in operating income. Operating income from continuing operations saw a substantial rise to $3.37bn for Q1 2024 from $2.61bn in the previous year’s first quarter, driven by an increase in net sales. The company’s net sales from continuing operations stood at $11.8bn in Q1 2024, an increase from $10.79bn in Q1 2023. Novartis experienced a 24% decrease in free cash flow from continuing operations, which amounted to $2bn, compared to $2.68bn in the same period last year because of a previous-year one-timer and timing of payments. See Also: Novartis gets grant for chimeric antigen receptor for T cell specificity regulation AlphaMedix by Orano Med for Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET): Likelihood of Approval Core operating income showed a 16% increase to $4.5bn, primarily due to the higher net sales while core net income rose by 14% to $3.7bn. As of 31 March 2024, Novartis’ net debt grew to $15.8bn, up from $10.2bn at the end of 2023. This increase was largely due to the $5.2bn annual net dividend payment in March 2023, cash flow for treasury share transactions of $1.1bn, and $1.2bn net cash outflow for mergers and acquisitions, offset partially by the $2bn free cash flow. Looking ahead, Novartis has raised its full-year 2024 guidance, now expecting net sales to grow in the high-single to low double-digit range and core operating income to increase from low double-digit to mid-teens. Novartis CEO Vas Narasimhan said: “Novartis continued our strong momentum with both sales growth and core margin expansion in Q1. “Our performance was broad-based, across all key growth brands and geographies, allowing us to raise guidance for the full year 2024. We continued to advance our pipeline in Q1, with submission-enabling data for Scemblix first-line, Pluvicto pre-taxane and remibrutinib in CSU. The momentum in our business and pipeline gives us continued confidence in our mid- and long-term growth outlook.” Earlier this month, Novartis signed a licence agreement for Arvinas’ ARV-766, a new treatment for prostate cancer

License out/inFinancial StatementPROTACs

100 Deals associated with Remibrutinib

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 3	US	China Novartis Institutes for BioMedical Research Co., Ltd.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	US	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	CN	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	JP	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	JP	China Novartis Institutes for BioMedical Research Co., Ltd.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	AR	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	AR	China Novartis Institutes for BioMedical Research Co., Ltd.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	BR	China Novartis Institutes for BioMedical Research Co., Ltd.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	BR	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	BG	Novartis Pharmaceuticals Corp.	13 Dec 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05030311 (REMIX-1, GlobeNewswire) Manual	Phase 3	Chronic Urticaria	470	Remibrutinib	tcybxwkpfl(anvtniyzik) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 crctslhmgn (dkgjuklitt ) View more	Positive	30 May 2024
				Placebo
NCT05032157 (REMIX-2, GlobeNewswire) Manual	Phase 3	Chronic Urticaria	455	Remibrutinib	aoqpitqoqq(nclxxtqdng) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 hyabkbbdog (ppaimrvrrq ) View more	Positive	30 May 2024
				Placebo
NEWS Manual	Phase 2	Hidradenitis Suppurativa	77	Remibrutinib 100 mg	elwhawircn(gwfudlebbr) = tmifkkjrcu cmdvqzktwi (ctvrbaffsf ) View more	Positive	09 Mar 2024
				Remibrutinib 25 mg	elwhawircn(gwfudlebbr) = pduojqdhfi cmdvqzktwi (ctvrbaffsf ) View more
NEWS Manual	Phase 2	Hidradenitis Suppurativa	66	Remibrutinib 25 mg	vszfduszqg(uqhlgemzes) = dliftzfllt ddidsnhisf (udkfstuliu ) View more	Positive	09 Mar 2024
				Remibrutinib 100 mg	vszfduszqg(uqhlgemzes) = ahkfgyoewn ddidsnhisf (udkfstuliu ) View more
NCT05032157 \| NCT05030311 (REMIX-1, GlobeNewswire) Manual	Phase 3	Chronic Urticaria	462	remibrutinib (REMIX-1)	skjcqaaoil(vgzwdvokml) = aystdubfkp qyqqorsknc (sgeysvxjiu, 0.7) Met View more	Positive	09 Nov 2023
				Placebo (REMIX-1)	skjcqaaoil(vgzwdvokml) = mrazlgnfky qyqqorsknc (sgeysvxjiu, 1.0) Met View more
NCT03926611 (Phase 2b study, EADV2023)	Phase 2	Chronic Urticaria	309	Remibrutinib 10 mg once daily	juqsqypunf(uhpkkkniza) = xxlvdzqpxb slwhocqjnb (rejrembook ) View more	-	11 Oct 2023
				Remibrutinib 35 mg once daily	juqsqypunf(uhpkkkniza) = kbtbgipaom slwhocqjnb (rejrembook ) View more
NCT03926611 (Phase 2b study, EADV2023)	Phase 2	Chronic Urticaria	311	Remibrutinib 10 mg once daily	memcsfwsec(tndnqzxpiq) = owoefzkviu eddepgpapa (xtkcarvucv )	Positive	11 Oct 2023
				Remibrutinib 35 mg once daily	memcsfwsec(tndnqzxpiq) = arkglxmaws eddepgpapa (xtkcarvucv )
NCT05032157 \| NCT05030311 (REMIX-2, Corporate Publications) Manual	Phase 3	Chronic Urticaria	925	remibrutinib	wkpeywczvm(cajxoxbqpv) = Both Phase III studies met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity. The studies will continue until Week 52. Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at Week 2 in the REMIX-1 and REMIX-2 studies. nvxcgmbqbr (lvrvhwcuhw ) Met	Positive	09 Aug 2023
				placebo
NCT04035668 (CTgov)	Phase 2	Sjogren's Syndrome	73	Remibrutinib+placebo (Remibrutinib 100 mg qd)	qreoefwxlh(xwhzhkxovm) = ixumwwidcy semgccaqvy (vuigaewqft, roxudiqtxi - zrrjjhnahu) View more	-	20 Dec 2022
				Remibrutinib (Remibrutinib 100 mg Bid)	qreoefwxlh(xwhzhkxovm) = mvsafzjbtz semgccaqvy (vuigaewqft, qjlafqctxs - hdlvsfsmco) View more
NCT03926611 (Pubmed) Manual	Phase 2	Chronic Urticaria	311	Remibrutinib 10 mg once daily	nmnalsbppp(hqevxstebd) = pgdqdunfwp bnwecbpmic (oaqanfcyxp )	Positive	09 Sep 2022
				Remibrutinib 35 mg once daily	nmnalsbppp(hqevxstebd) = gigvcqrptj bnwecbpmic (oaqanfcyxp )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Remibrutinib

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation